UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000056436 |
|---|---|
| Receipt number | R000064494 |
| Scientific Title | Evaluation of the eye-drop container using the flange-colored nozzles on the visibility |
| Date of disclosure of the study information | 2024/12/12 |
| Last modified on | 2025/06/16 16:54:52 |
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Basic information
Public title
Evaluation of the eye-drop container using the flange-colored nozzles on the visibility
Acronym
Evaluation of the eye-drop container using the flange-colored nozzles on the visibility
Scientific Title
Evaluation of the eye-drop container using the flange-colored nozzles on the visibility
Scientific Title:Acronym
Evaluation of the eye-drop container using the flange-colored nozzles on the visibility
Region
| Japan |
Condition
Condition
Glaucoma
Classification by specialty
| Ophthalmology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To evaluate the influence of nozzle tips of eye-drop containers using the flange-colored nozzles on the visibility, in glaucoma patients.
Basic objectives2
Others
Basic objectives -Others
visibility
Trial characteristics_1
Exploratory
Trial characteristics_2
Others
Developmental phase
Not applicable
Assessment
Primary outcomes
Visibility of nozzle tips of eye-drop containers, between the colorless nozzles and the flange-colored nozzles.
Key secondary outcomes
Preference of nozzle tips between the colorless nozzles and the flange-colored nozzles.
Visibility of nozzle tips between the colorless nozzles and the flange-colored nozzles, stratified by central foveal threshold (over 31dB and under 31dB)
Preference of nozzle tips between the colorless nozzles and the flange-colored nozzles, stratified by central foveal threshold (over 31dB and under 31dB)
Patient background factors affecting to visibility and Preference (including near vision and color anomaly)
Base
Study type
Observational
Study design
Basic design
Randomization
Randomization unit
Blinding
Control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
Purpose of intervention
Type of intervention
Interventions/Control_1
Interventions/Control_2
Interventions/Control_3
Interventions/Control_4
Interventions/Control_5
Interventions/Control_6
Interventions/Control_7
Interventions/Control_8
Interventions/Control_9
Interventions/Control_10
Eligibility
Age-lower limit
| 18 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
1) 18 years of age or older, regardless of gender
2) Patients with glaucoma in one or both eyes, and receiving eye drop treatment
Key exclusion criteria
1) Patients with diseases that may affect visual field testing (e.g., cataracts)
2) Patients that cannot instill eye drops by themselves with disability
3) Patients who have difficulty in performing the Humphrey visual field test
4) Patients deemed by the physician to be inappropriate to participate in this study
Target sample size
150
Research contact person
Name of lead principal investigator
| 1st name | Shiro |
| Middle name | |
| Last name | Mizoue |
Organization
Ehime University
Division name
Ophthalmology
Zip code
7910295
Address
454 Shitsukawa, Toon-city, Ehime
TEL
0899605361
mizoue@m.ehime-u.ac.jp
Public contact
Name of contact person
| 1st name | Shuzo |
| Middle name | |
| Last name | Okuno |
Organization
Ehime University
Division name
Ophthalmology
Zip code
7910295
Address
454 Shitsukawa, Toon-city, Ehime
TEL
0899605361
Homepage URL
s.okuno024@gmail.com
Sponsor or person
Institute
Shiro Mizoue
Institute
Department
Personal name
Funding Source
Organization
SENJU Pharmaceutical Co.,ltd.
Organization
Division
Category of Funding Organization
Profit organization
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Review Board of Human Rights and Ethics for Clinical Studies
Address
2-2-1 Kyobashi, Chuo-ku, Tokyo
Tel
03-6665-0572
soudan@hurecs.org
Secondary IDs
Secondary IDs
NO
Study ID_1
Org. issuing International ID_1
Study ID_2
Org. issuing International ID_2
IND to MHLW
Institutions
Institutions
南松山病院（愛媛県）Minami-matsuyama Hospital
Other administrative information
Date of disclosure of the study information
| 2024 | Year | 12 | Month | 12 | Day |
Related information
URL releasing protocol
Publication of results
Unpublished
Result
URL related to results and publications
Number of participants that the trial has enrolled
Results
Results date posted
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Participant flow
Adverse events
Outcome measures
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
No longer recruiting
Date of protocol fixation
| 2024 | Year | 10 | Month | 28 | Day |
Date of IRB
| 2024 | Year | 11 | Month | 27 | Day |
Anticipated trial start date
| 2024 | Year | 12 | Month | 08 | Day |
Last follow-up date
| 2025 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
| 2025 | Year | 03 | Month | 31 | Day |
Date trial data considered complete
Date analysis concluded
Other
Other related information
Visibility
Management information
Registered date
| 2024 | Year | 12 | Month | 12 | Day |
Last modified on
| 2025 | Year | 06 | Month | 16 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000064494
